Stability Scientist

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Job Description Summary As Stability Scientist you will be responsible for the design and documentation of stability studies to support product lifecycle management. This is a subject matter expert role in the Global Product Management Team. In this position you will collaborate with other colleagues from Supply Chain, Quality Assurance, Regulatory Affairs, Research and Development to execute and deliver required stability studies through the product lifecycle management phases. You will report to the Manufacturing Development Leader. This role is based in Oslo and requires some travel to other manufacturing sites globally. Job Description GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. GE HealthCare Pharmaceutical Diagnostics (PDx) is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world . Essential Responsibilities Act as a stability subject matter expert (SME), providing scientific and technical guidance in line with ICH, GMP, and regulatory requirements. Develop, execute, and maintain stability strategies across all phases of the product lifecycle. Author, review, and maintain technical and regulatory documentation, including protocols, reports, SOPs, and submission documents. Ensure timely stability studies, including data analysis, trend evaluation, and determination of shelf life and storage conditions. Collaborate cross-functionally (Analytical, Quality, Regulatory, Manufacturing, R&D, Supply Chain) to deliver integrated stability strategies. Communicate project progress, risks, and key findings effectively to stakeholders. Lead and support investigations, including root cause analysis, CAPA implementation, and risk assessments. Ensure compliance and audit readiness, including adherence to cGMP, ICH, FDA/EMA standards, participation in regulatory interactions, and early risk mitigation. Basic Qualifications and Requirements PhD (preferred) or MSc in Chemistry or related discipline with relevant experience. Solid professional experience in a GMP pharmaceutical environment with expertise in stability program design, regulatory expectations, and CMC principles. Demonstrated track record documenting scientific strategy successfully and supporting regulatory submissions and audits. Proven experience in a GMP-regulated pharmaceutical environment with strong focus on stability Experience across multiple CMC domains including analytical development, manufacturing sciences, technology transfer, and on‑market product support. Proven ability to interpret data, solve complex technical challenges, and communicate effectively across functions and leadership levels. Lean/Operational Excellence training beneficial. Willingness to travel internationally (10-20%). Behaviors We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.

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